CN116847902A

CN116847902A - Facilitating delivery of devices with high friction braids

Info

Publication number: CN116847902A
Application number: CN202180093848.1A
Authority: CN
Inventors: 刘千; 布莱恩·雷诺兹; 蒂莫西·鲁贝施
Original assignee: Boston Scientific Scimed Inc
Current assignee: Boston Scientific Scimed Inc
Priority date: 2020-12-23
Filing date: 2021-12-22
Publication date: 2023-10-03
Also published as: WO2022140635A1; US20220193392A1; EP4240468A1

Abstract

Disclosed herein is a delivery device for a percutaneous medical device. The delivery device comprises: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the envelope member is configured to removably cover the deployment portion with the envelope wall; the tether assembly is configured to facilitate removal of the cuff member from covering the deployment portion and extraction of the cuff member from the delivery lumen.

Description

Facilitating delivery of devices with high friction braids

Technical Field

The present disclosure relates to a delivery aid for a percutaneous circulatory support device. More particularly, the present disclosure relates to a delivery aid for an integrated braided cannula in a circulatory support pump.

Background

The circulatory support device supports a pumping action of the heart. These devices may be placed through a valve opening, such as, for example, an aortic valve. Typically, the circulatory support device has a polymer coating that, for example, protects the underlying components, such as the mesh of the circulatory support device. However, such coatings can make it difficult for the circulatory support device to travel through the lumen for delivering such devices to the treatment site.

Disclosure of Invention

In example 1, a delivery device for a percutaneous medical device includes: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the cuff member is configured to removably cover the deployment portion with a cuff wall; and the tether assembly is configured to facilitate removal of the cuff member from the covered deployment portion and extraction of the cuff member from the delivery lumen.

In example 2, the delivery device of example 1, wherein the tether assembly is fixedly connected to the cuff member.

In example 3, the delivery device of example 1 or 2, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member; wherein the collar is optionally configured to inhibit movement of the cuff member relative to the percutaneous medical device.

In example 4, the delivery device of one of examples 1 to 3, wherein the distal portion of the cuff member includes a fixation member configured to inhibit expansion of the distal portion of the cuff member when the fixation member is secured and to allow expansion of the distal portion of the cuff member when the fixation member is released; and wherein the fixation member optionally comprises silicone.

In example 5, the delivery device of one of examples 1 to 4, wherein the cuff member is a mesh-woven cuff member; and wherein the jacket member optionally comprises nitinol.

In example 6, a delivery assembly for a percutaneous medical device includes a delivery tube having an inner lumen configured to removably receive a deployment portion of the percutaneous medical device and a delivery device; and the delivery device comprises: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the cuff member is configured to removably cover the deployment portion with a cuff wall; and the tether assembly is configured to facilitate extraction of the cuff member from the covered deployment portion and extraction of the cuff member from the delivery lumen.

In example 7, the delivery assembly of example 6, wherein the tether assembly is fixedly connected to the cuff member.

In example 8, the delivery assembly of example 6 or 7, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member; and wherein the collar is optionally configured to inhibit movement of the cuff member relative to the percutaneous medical device.

In example 9, the delivery assembly of one of examples 6-8, wherein the distal portion of the cuff member includes a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released.

In example 10, the delivery assembly of one of examples 6 to 9, wherein the jacket member is a mesh-woven jacket member; and wherein the fixation member optionally comprises silicone.

In example 11, the delivery assembly of one of examples 6 to 10, wherein the jacket member comprises nitinol.

In example 12, a method of delivering a percutaneous medical device includes surrounding a deployed portion of the percutaneous medical device with a delivery device, the delivery device comprising: a sheath member including a sheath wall, a sheath aperture formed at the sheath wall such that the sheath member is configured to receive a deployment portion of the percutaneous medical device through the sheath aperture, the sheath member configured to removably cover the deployment portion with the sheath wall, and a tether assembly configured to facilitate withdrawal of the sheath member from the covered deployment portion and withdrawal of the sheath member from the delivery lumen; inserting the deployment portion into the body cavity along with the cuff member; and withdrawing the cuff member from the body cavity.

In example 13, the method of example 12, further comprising withdrawing the deployment portion into the delivery tube along with the cuff member, and wherein inserting the deployment portion comprises inserting the delivery tube into the body lumen, and moving the deployment portion distally relative to the delivery tube such that the deployment portion is external to the delivery tube.

In example 14, the method of example 12 or 13, wherein the distal portion of the cuff member includes a fixation member configured to inhibit expansion of the distal portion of the cuff member when the fixation member is secured and to allow expansion of the distal portion of the cuff member when the fixation member is released, and wherein the tether assembly is configured to transition the fixation member from the secured state to the unsecured state, wherein inserting the deployment portion into the body cavity along with the cuff member occurs with the cuff member in the secured state of the cuff member, and wherein the method further comprises transitioning a portion of the cuff member from the secured state to the unsecured state.

In example 15, the method of one of examples 12-14, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member, and wherein the cuff aperture is positioned distally relative to the collar.

In example 16, a delivery device for a percutaneous medical device includes: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the cuff member is configured to removably cover the deployment portion with a cuff wall; and the tether assembly is configured to facilitate removal of the cuff member from the covered deployment portion and extraction of the cuff member from the delivery lumen.

In example 17, the delivery device of example 16, wherein the tether assembly is fixedly connected to the cuff member.

In example 18, the delivery device of example 16, wherein the tether assembly includes a collar that connects the tether assembly to the cuff member.

In example 19, the delivery device of example 18, wherein the collar is configured to inhibit movement of the cuff member relative to the percutaneous medical device.

In example 20, the delivery device of example 16, wherein the distal portion of the cuff member includes a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released.

In example 21, the delivery device of example 20, wherein the jacket member is a mesh-grid jacket member.

In example 22, the delivery device of example 21, wherein the fixation member comprises silicone.

In example 23, the delivery device of example 16, wherein the cuff member comprises nitinol.

In example 24, a delivery assembly for a percutaneous medical device includes a delivery tube having an inner lumen configured to removably receive a deployment portion of the percutaneous medical device and a delivery device; and the delivery device comprises: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the cuff member is configured to removably cover the deployment portion with a cuff wall; and the tether assembly is configured to facilitate extraction of the cuff member from the covered deployment portion and extraction of the cuff member from the delivery lumen.

In example 25, the delivery assembly of example 24, wherein the tether assembly is fixedly connected to the cuff member.

In example 26, the delivery assembly of example 24, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member.

In example 27, the delivery assembly of example 26, wherein the collar is configured to inhibit movement of the cuff member relative to the percutaneous medical device.

In example 28, the delivery assembly of example 24, wherein the distal portion of the cuff member includes a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released.

In example 29, the delivery assembly of example 28, wherein the jacket member is a mesh-grid jacket member.

In example 30, the delivery assembly of example 29, wherein the fixation member comprises silicone.

In example 31, the delivery assembly of example 24, wherein the jacket member comprises nitinol.

In example 32, a method of delivering a percutaneous medical device includes surrounding a deployed portion of the percutaneous medical device with a delivery device, the delivery device comprising: a sheath member including a sheath wall, a sheath aperture formed at the sheath wall such that the sheath member is configured to receive a deployment portion of the percutaneous medical device through the sheath aperture, the sheath member configured to removably cover the deployment portion with the sheath wall, and a tether assembly configured to facilitate withdrawal of the sheath member from the covered deployment portion and withdrawal of the sheath member from the delivery lumen; inserting the deployment portion into the body cavity along with the cuff member; and withdrawing the cuff member from the body cavity.

In example 33, the method of example 32, further comprising withdrawing the deployment portion into the delivery tube along with the cuff member, and wherein inserting the deployment portion comprises inserting the delivery tube into the body lumen, and moving the deployment portion distally relative to the delivery tube such that the deployment portion is external to the delivery tube.

In example 34, the method of examples 32 to 32, wherein the distal portion of the cuff member includes a fixation member configured to inhibit expansion of the distal portion of the cuff member when the fixation member is secured and to allow expansion of the distal portion of the cuff member when the fixation member is released, and wherein the tether assembly is configured to transition the fixation member from the secured state to the unsecured state, wherein inserting the deployment portion into the body cavity along with the cuff member occurs with the cuff member in the secured state of the cuff member, and wherein the method further comprises transitioning a portion of the cuff member from the secured state to the unsecured state.

In example 35, the method of example 34, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member, and wherein the cuff aperture is positioned distally relative to the collar.

While multiple embodiments are disclosed, other embodiments of the application will be apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the application. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

Drawings

Fig. 1A illustrates a conceptual diagram of a circulatory support device including a cannula and an adapter, according to some aspects of the present disclosure.

FIG. 1B illustrates a side view of the circulatory support of FIG. 1A, including a pump, in accordance with some aspects of the present disclosure.

Fig. 2 illustrates a side view of a delivery assembly according to some aspects of the present disclosure.

Fig. 3A illustrates an envelope member in accordance with some aspects of the present disclosure.

Fig. 3B illustrates the cuff member of fig. 3A positioned around the deployment portion, in accordance with some aspects of the present disclosure.

Fig. 3C illustrates a second example of an envelope member 220 according to some aspects of the present disclosure.

Fig. 4 illustrates a flow chart of a method in accordance with some aspects of the present disclosure.

While the application is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. However, the application is not limited to the specific embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the application as defined by the appended claims.

Detailed Description

The present application relates to a circulatory support device having a reduced delivery force than conventional embodiments. For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the examples illustrated in the drawings and described below. The examples disclosed herein are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed in the following detailed description. Rather, these exemplary embodiments are chosen and described so that others skilled in the art may utilize their teachings. Multiple (e.g., all) features in a given instance used in all instances do not exceed the scope of the present disclosure. Accordingly, a drawing should not be construed as having any dependency or requirement relating to any single component or combination of components illustrated herein. Moreover, in the examples, the various components shown in a given figure may be integrated with many of the other components shown herein (and/or components not shown), all of which should be considered within the scope of the present disclosure.

Fig. 1A illustrates a conceptual diagram of a circulatory support device 102, the circulatory support device 102 including a cannula 104 and an adapter 108, according to an embodiment of the subject matter disclosed herein. The circulatory support 102 is shown disposed within the heart 110. According to an embodiment, the circulatory support device 102 may include a ventricular assist device (shown in fig. 1B), such as a pump, that is coupled to the cannula 104 via the adapter 108. The ventricular assist device is configured to pump blood from the subject left ventricle 112 into the subject's aorta 114. In embodiments, the circulatory support 102 may be used to treat cardiogenic shock and other heart failure conditions.

In an embodiment, the distal portion 116 of the circulatory support 102 is disposed in the left ventricle 112. The intermediate portion 118 of the circulatory support 102 extends through the aortic valve 120 such that the proximal portion 122 of the cannula 104 extends into the aorta 114. In an embodiment, the proximal portion 122 of the cannula 104 is coupled to the adapter 108, and the adapter 108 is coupled to the circulatory support 102. During operation, the circulatory support 102 draws blood from the left ventricle 112, through the cannula 104 of the circulatory support 102, and releases into the aorta 114. Additionally or alternatively, the circulatory support 102 may be used to facilitate pumping blood from some other aspect of the subject's vasculature into an adjacent portion of the vasculature.

Fig. 1B illustrates a side view of the circulatory support device 102 illustrated in fig. 1A, the circulatory support device 102 including a ventricular assist device 103, in accordance with an embodiment of the presently disclosed subject matter.

As mentioned above, the cannula 104 may include a proximal portion 122, a middle portion 118, and a distal portion 116. The intermediate portion 118 may include a mesh 124 extending between the proximal portion 122 and the distal portion 116. In embodiments, the mesh 124 may have various weave angles and/or different weave angles, as explained in more detail below. In an embodiment, the proximal portion 126 of the mesh 124 may be tapered. The tapered proximal portion 126 may transition the mesh 124 from a larger diameter near the distal end 128 of the proximal portion 126 (e.g., greater than or equal to 5 millimeters (mm)) to a smaller diameter near the proximal end 130 of the mesh 124. In an embodiment, the mesh 124 may collapse to a smaller diameter for delivery into the heart 110. Once disposed within heart 110, mesh 124 may expand to its larger diameter. By expanding to a larger diameter than its delivery configuration, the cannula 104 may provide a larger flow rate than a smaller diameter cannula 104 that is not expandable. In an embodiment, the mesh 124 may be designed to sufficiently withstand the pressure gradient between the inside and outside of the cannula 104.

In an embodiment, the mesh 124 is coated with a film to form a conduit through the cannula 104 from the distal portion 116 to the proximal portion 122. In an embodiment, the membrane may be silicone. In an embodiment, the cannula 104 is formed from a plurality of nitinol wires having a diameter of 0.008 ". However, this is merely an example, and other types of wires having other diameters may be used to form the cannula 104. Additionally or alternatively, wires having different diameters may be used to form the cannula 104. In an embodiment, the cannula 104 may be formed from some nitinol wires (e.g., 6 wires to 48 wires). While protective, the film coated on the mesh 124 can have a substantial external resistance that can prove cumbersome during delivery of the circulatory support 102, such as by increasing the delivery force required to advance the cannula 104 through the delivery lumen 206 during placement and/or operation.

Turning to fig. 2, a delivery assembly 200 for a percutaneous medical device 102, such as a circulatory support device 102, is shown. The percutaneous medical device 102 includes a deployment portion 104, such as a cannula 104. For purposes of illustration, the proximal direction is the right-to-left direction in the figure, and the distal direction is the left-to-right direction in the figure. In addition, hereinafter, for simplicity of illustration, the percutaneous medical device 102 will be collectively referred to as 102 and the deployment portion 104 will be collectively referred to as 104. It should be noted, however, that the use of a delivery assembly 200 having other percutaneous medical devices 102 and deployment portions 104 thereof is also contemplated and, thus, does not exceed the scope of the present disclosure.

In view of the resistive nature of the membrane, the delivery assembly 200 may include an introducer 204, a delivery lumen 206 formed in the introducer 204, and a delivery device 210 to facilitate delivery of the percutaneous medical device 102. The delivery lumen 206 may be configured to removably receive the deployment portion 104 of the percutaneous medical device 102. For example, the introducer 204 may house the deployment portion 104 until it is inserted into the patient's vasculature. In some examples, the delivery lumen 206 is configured to constrain the deployment portion 104 or a combination of the deployment portion 104 and the delivery device 210 (e.g., by having a smaller diameter). In other examples, the delivery lumen 206 does not constrain the deployment portion 104 or the combination of the deployment portion 104 and the delivery device 210. The delivery device 210 may include a cuff member 220 and a tether assembly 230. The envelope member 220 may be configured to removably cover the deployment portion 104 with an envelope wall 222. The tether assembly 230 may be configured to facilitate extraction of the cuff member 220 from covering the deployment portion 104 and extraction of the cuff member 220 from the delivery lumen 206.

As noted throughout, variations of the present disclosure are contemplated. For example, while shown and discussed herein as including an introducer 204, it is contemplated that some examples of the delivery assembly 200 may not include an introducer 204 or alternatively include differently shaped or formed members that function similarly to the introducer 204 and thus do not exceed the scope of the present disclosure. In addition, while shown as being closed at both ends, the jacket member 220 may have one open end and one closed end, or both open ends. Even these examples are only some of those that would be conceivable to a person skilled in the art and that will be appreciated upon an understanding of the present disclosure.

The resistance of the delivery device 210 to insertion through the delivery lumen 206 may be defined as the delivery force. The delivery force may be a function of the depth of insertion such that the delivery force is highest at or shortly after initial insertion and lowest near delivery. As noted above, the percutaneous medical device 102 has a substantial external resistance in the membrane, which results in high delivery forces. Conventional measures for reducing delivery forces include lubricating and/or wetting one or more portions of the delivery assembly 200, such as the cannula 104, the introducer 204, or both. However, these measures can still lead to an undesirable relatively high delivery force. In an example, the jacket member 220 may provide a lower delivery force than the percutaneous medical device 102. In addition, the delivery device 210 may provide a lower delivery force than, for example, conventional lubrication. In this regard, the delivery force may be reduced by up to about 4 times in some embodiments, and about 3 times, 2.5 times, 2 times, 1.5 times, etc. in other examples.

When positioned around a portion of the deployment portion 104, the cuff member 220 may reduce the delivery force required to deliver the deployment portion 104 through the delivery lumen 206. The jacket member 220 may include a jacket wall 222, a jacket aperture 223 formed on the jacket wall 222, and a tether assembly 230 extending from the jacket wall 222, the jacket aperture 223 being formed on the jacket wall 222 such that the jacket member 220 is configured to receive the deployment portion 104 of the percutaneous medical device 102 through the jacket aperture 223. During deployment, the deployment portion 104 may be received in the cuff aperture 223 (e.g., at the distal portion, the proximal portion, or somewhere in between) such that a portion (e.g., all) of the deployment portion 104 is located within the cuff member 220. So configured, the deployment portion 104, along with the cuff member 220, may be inserted into the delivery lumen 206 with reduced delivery force. In these cases, the cuff member 220 may conform to the deployment portion 104 and the delivery lumen 206. As discussed further below, in an example, the tether assembly 230 can be used to withdraw (e.g., move proximally via the tether assembly 230) the cuff member 220 only from the delivery lumen 206 prior to deployment of the deployment portion 104. In these cases, the envelope member 220 is moved from covering or surrounding a portion of the deployment portion 104 to be withdrawn (e.g., moved distally relative to the deployment portion 104) to expose the deployment portion 104.

Fig. 3A and 3B illustrate various views of a delivery device 210 according to some aspects of the present disclosure. Fig. 3A shows a first example of the jacket structure 220. Fig. 3B shows the cuff member 220 of fig. 3A positioned about the deployment portion 104. Fig. 3C shows a second example of the jacket structure 220.

In an example, as shown herein in these figures, the jacket member 220 is a mesh-woven jacket member 220 made of a substantially flexible material. In an example, the jacket member 220 includes nitinol (e.g., a plurality of nitinol strands) or other similar material surrounding an interior space that may be large enough to accommodate the deployment portion 104. In this regard, the mesh enclosure member 220 may be a flexible structure that is deformable such that manipulation of one portion of the mesh enclosure member 220 may manipulate another portion of the mesh enclosure member 220. As an example, the mesh-wrap member 220 may initially be a generally tubular structure having opposite ends and maneuvered at the opposite ends such that the mesh-wrap member 220 becomes larger in diameter at the middle portion while the opposite ends are reduced in diameter. In these cases, the shape of the longitudinal cross-section (e.g., taken in the proximal and distal directions) of the mesh-grid envelope member 220 may be generally elliptical. As a result, the mesh-wrap member 220 fits relatively loosely over the deployment portion 104, but is not so loose, e.g., does not cause tightening during insertion of the mesh-wrap member 220 into the delivery lumen 206 along with the deployment portion 104. Other types of cross-sections (e.g., eccentric, symmetrical, etc.), corresponding maneuvers, and corresponding fits (e.g., tethered fits) on deployment portion 104 are contemplated and should not be construed as outside the scope of the present application.

The elastic portion may secure the mesh enclosure member 220 to the deployment portion 104. In an example, the distal portion of the jacket member 220 may include a securing member 224, the securing member 224 configured to inhibit expansion of the distal portion of the jacket member 220 when the securing member 224 is secured and to allow expansion of the distal portion of the jacket member 220 when the securing member 224 is released. In an example, the fixation member 224 may include silicone or similar materials. In this regard, the fixation member 224 may be an elastic portion of the mesh-wrap member 220 and may have a level of elasticity (e.g., radial elasticity) that resists the delivery force such that the wrap member 220 is inhibited from inadvertently expanding, thereby prematurely releasing the deployment portion 104 from the wrap member 220.

The configuration of the delivery device 210 may be advantageous to accommodate various forces (e.g., delivery force and grip force) experienced by the delivery device 210 during operation. In an example, the length of the tether assembly 230 may be longer than the length of the introducer 204 such that as the cuff member 220 is advanced through the introducer 204 to the deployment site where the deployment portion 104 is deployed, the graspable amount of the tether assembly 230 still protrudes from the proximal end of the introducer 204. The tether assembly 230 may be constructed of one or more materials, each of which is sufficiently rigid to withstand the delivery force and/or the amount of graspable force experienced by the envelope member 220 in inserting (e.g., withdrawing) the deployment portion 104 into the envelope member 220. The gripping force may be the force required to expand the fixation member 224. While in some cases the gripping force may be greater than the delivery force, in many cases the gripping force may be less than or equal to the delivery force.

In an example, the tether assembly 230 may be integrally manufactured with the envelope member 220 or may be a separate component connected to the envelope member 220. When provided as a separate component of the envelope member 220, the tether assembly 230 may be connected to the envelope member 220 in various ways (e.g., fixedly or rigidly). As seen in fig. 3A and 3B, in a first example, the tether assembly 230 may include a collar 350, the collar 350 connecting the tether assembly 230 to the cuff member 220 (e.g., along the cuff wall 222 or at a distal or proximal portion of the cuff member 220). The nature of such a connection may be relatively rigid or semi-rigid. In an example, the collar 350 may be configured to inhibit movement of the cuff member 220 relative to the percutaneous medical device 102. For example, the deployment portion 104 (or an adjacent portion at the distal end of the catheter housing the deployment portion 104) may have a first diameter, and the collar 350 may have a second diameter that is less than the first diameter. As seen in fig. 3C, in a second example, the tether assembly 230 may be connected to the cuff member 220 via an adhesive cap 360, which adhesive cap 360 may optionally separate the cuff member to one side such that the cuff member tapers from a distal portion to a proximal portion thereof. Note that adhesive cap 360 may optionally be disposed on the distal portion of the cuff member such that either end comprises a non-invasive adhesive cap. With the connection between the cuff member 220 and the tether assembly 230 so configured (e.g., as shown in fig. 3A-3C), the cuff member may be inhibited from traveling past the proximal end of the deployment portion 104. In these cases, movement of the cuff member 220 relative to the deployment portion 104 may be temporarily inhibited (e.g., until a grasping force is applied to the tether assembly 230).

During operation, the tether assembly 230 may be configured to actuate the securing member 224 between the secured and unsecured states. For example, the tether assembly 230 may actuate the fixation member 224 from a fixed state at the time of delivery of the percutaneous medical device 102 to an unfixed state prior to the time of deployment of the deployment portion 104 of the percutaneous medical device 102. For example, as discussed in further detail below, the tether assembly 230 may cause the fixation member 224 to expand by pulling the tether assembly 230 in a proximal direction. In this regard, the fixation member 224 can be contiguous with the deployment portion 104. In these cases, radially outward forces that gradually move the fixation member 224 along a portion of the deployment portion 104 may assist in expanding the fixation member 224.

Additionally or alternatively, the tether assembly 230 may be configured to facilitate extraction of the cuff member 220 from a state covering the deployment portion 104 and/or from the delivery lumen 206. For example, pulling the tether assembly 230 in the proximal direction may cause proportional movement of the envelope member 220. First, the envelope member 220 may be delivered in a state covering the deployment portion 104 (e.g., in a constrained configuration). When the sheath member 220 is in the expanded configuration prior to deployment of the deployment portion 104, the tether assembly 230 may be pulled with a grasping force, facilitating proximal movement of the sheath member 220 to no longer cover the deployment portion 104. Additionally or alternatively, the tether assembly 230 may then be pulled with a grasping force to facilitate extraction of the cuff member 220 from the delivery lumen 206.

While in some examples a single tether, the tether assembly 230 may include multiple tethers in other examples. For example, the plurality of tethers may include a first tether and a second tether. The first tether may be configured to actuate the securing member 224 from a secured state to an unsecured state. The second tether may be configured to facilitate extraction of the cuff member 220 from a state covering the deployment portion 104 and to facilitate extraction of the cuff member 220 from the delivery lumen 206. In some examples, the first tether 231 and the second tether 232 may comprise different materials, each of which is better suited for its particular use. For example, the first tether may comprise a more rigid material than the second tether, and vice versa. In other examples, the first tether and the second tether may generally comprise the same material.

The present disclosure includes methods of delivering a percutaneous medical device. As shown in fig. 4, such a method 400 may include, at step 402, surrounding a deployed portion of a percutaneous medical device with a delivery device. The delivery device may be similar to those disclosed elsewhere herein, including delivery device 210. For example, the delivery device may include a cuff member and a tether assembly. The cuff member may include a cuff wall and a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture. The tether assembly may extend from the enclosure wall. The cuff member may be configured to removably cover the deployment portion with a cuff wall. The tether assembly may be configured to facilitate extraction of the cuff member from a condition covering the deployment portion and extraction of the cuff member from the delivery lumen. The method 400 may include inserting 404 the deployment portion into the body cavity along with the cuff member. The method 400 may include withdrawing 406 the cuff member from the body lumen.

An example of the method 400 may include a multi-step insertion process. In an example, the method 400 may include withdrawing the deployment portion into the delivery tube along with the cuff member. In an example, inserting the deployment portion can include inserting the delivery tube into the body lumen and moving the deployment portion distally relative to the delivery tube such that the deployment portion is external to the delivery tube.

In an example, as noted above, the distal portion of the cuff member may include a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released. The tether assembly may be configured to transition the securing member from the secured state to the unsecured state. Insertion of the deployment section into the body cavity along with the cuff member may occur with the cuff member in a fixed state. The method 400 may include transitioning a portion of the envelope member from the secured state to the unsecured state.

In an example, as noted above, the tether assembly may include a collar that connects the tether assembly to the cuff member at a proximal end of the cuff member. The cuff aperture may be positioned distally relative to the collar.

It is well known that methods involving one or more steps are not limited by the order presented, unless there is a clear or implied statement in the specification or the claims themselves. It is also clear that the illustrated method is only some of the disclosed examples, and that certain steps may be added or omitted without departing from the scope of the present disclosure. Such steps may include incorporating the apparatus, system or method, or components thereof, as well as conventional, customary and regular components as known in the art.

The connecting lines shown in the various figures contained herein are intended to represent example functional relationships and/or physical couplings between the various elements. It should be noted that many alternative or additional functional relationships or physical connections may be present in a practical system. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced, however, are not to be construed as a critical, required, or essential feature or element. Accordingly, the scope should not be limited except by the appended claims, wherein reference to a singular element is not intended to mean "one and only one" unless explicitly so stated, but rather "one or more". Furthermore, where a phrase similar to "A, B or at least one of C" is used in the claims, it is intended that the phrase should be construed to mean: a may be present alone in one embodiment, B may be present alone in one embodiment, C may be present alone in one embodiment, or any combination of elements A, B or C may be present in a single embodiment, e.g., a and B, A and C, B and C, or a and B and C.

Reference in the detailed description herein to "one embodiment," "an example embodiment," etc., means that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the purview of one skilled in the art to affect such feature, structure, or characteristic in connection with other ones of the embodiments whether or not explicitly described. It will be apparent to those skilled in the relevant art after reading this specification how to implement the present disclosure in alternative embodiments.

Furthermore, no element, component, or method step in the present disclosure is intended to be dedicated to the public regardless of whether the element, component, or method is explicitly recited in the claims. The claim elements herein are not to be construed in accordance with the specification of 35u.s.c.112 (f) unless explicitly recited using the phrase "for. As used herein, the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

While this disclosure has been described as having an exemplary design, the present application may be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the application using its general principles. In addition, the present application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this application pertains.

Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the application. For example, although the embodiments described above refer to particular features, the scope of the application also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present application is intended to embrace all such alternatives, modifications and variances which fall within the scope of the appended claims, and all equivalents thereof.

Claims

1. A delivery device for a percutaneous medical device, the delivery device comprising: a cuff member and a tether assembly, the cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture; the tether assembly extending from the envelope wall; the envelope member is configured to removably cover the deployment portion with the envelope wall; and the tether assembly is configured to facilitate removal of the cuff member from covering the deployment portion and extraction of the cuff member from the delivery lumen.

2. The delivery device of claim 1, wherein the tether assembly is fixedly connected to the cuff member.

3. The delivery device of claim 1, wherein the tether assembly comprises a collar connecting the tether assembly to the cuff member, wherein the collar is optionally configured to inhibit movement of the cuff member relative to the percutaneous medical device.

4. The delivery device of claim 1, wherein a distal portion of the cuff member comprises a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released; and wherein the fixation member optionally comprises silicone.

5. The delivery device of claim 1, wherein the cuff member is a mesh-braided cuff member; and wherein the jacket member optionally comprises nitinol.

6. A delivery assembly for a percutaneous medical device, the delivery assembly comprising:

a delivery tube having an inner lumen configured to removably receive a deployment portion of the percutaneous medical device; and

a delivery device, the delivery device comprising: a cuff member including a cuff wall, a cuff aperture formed at the cuff wall such that the cuff member is configured to receive a deployment portion of the percutaneous medical device through the cuff aperture, and a tether assembly extending from the cuff wall; the envelope member is configured to removably cover the deployment portion with the envelope wall; the tether assembly is configured to facilitate extraction of the cuff member from the deployment portion and extraction of the cuff member from the delivery lumen.

7. The delivery assembly of claim 6, wherein the tether assembly is fixedly connected to the cuff member.

8. The delivery assembly of claim 6, wherein the tether assembly comprises a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member, and wherein the collar is optionally configured to inhibit movement of the cuff member relative to the percutaneous medical device.

9. The delivery assembly of claim 6, wherein a distal portion of the cuff member comprises a securing member configured to inhibit expansion of the distal portion of the cuff member when the securing member is secured and to permit expansion of the distal portion of the cuff member when the securing member is released.

10. The delivery assembly of claim 9, wherein the cuff member is a mesh-braided cuff member; and wherein the fixation member optionally comprises silicone.

11. The delivery assembly of claim 6, wherein the cuff member comprises nitinol.

12. A method of delivering a percutaneous medical device, the method comprising:

surrounding a deployed portion of the percutaneous medical device with a delivery device, the delivery device comprising: a sheath member and a tether assembly, the sheath member including a sheath wall, a sheath aperture formed at the sheath wall such that the sheath member is configured to receive a deployment portion of the percutaneous medical device through the sheath aperture, the sheath member configured to removably cover the deployment portion with the sheath wall, and the tether assembly configured to facilitate withdrawal of the sheath member from covering the deployment portion and withdrawal of the sheath member from a delivery lumen;

inserting the deployment portion into a body cavity along with the cuff member; and

the cuff member is withdrawn from the body lumen.

13. The method of claim 12, further comprising withdrawing the deployment portion into a delivery tube along with the cuff member, and wherein inserting the deployment portion comprises inserting the delivery tube into the body lumen, and moving the deployment portion distally relative to the delivery tube such that the deployment portion is external to the delivery tube.

14. The method of claim 12, wherein a distal portion of the cuff member includes a fixation member configured to inhibit expansion of the distal portion of the cuff member when the fixation member is secured and to allow expansion of the distal portion of the cuff member when the fixation member is released, and wherein the tether assembly is configured to transition the fixation member from a secured state to an unsecured state, wherein inserting the deployment portion along with the cuff member into a body cavity occurs with the cuff member in the secured state, and wherein the method further comprises transitioning a portion of the cuff member from the secured state to the unsecured state.

15. The method of claim 14, wherein the tether assembly includes a collar connecting the tether assembly to the cuff member at a proximal end of the cuff member, and wherein the cuff aperture is positioned distally relative to the collar.